Pancreatic Stent, Post-ERCP Acute Pancreatitis, Ultrasound, X-rays
Conditions
Keywords
Post-ERCP Acute Pancreatitis, Pancreatic Stent, Ultrasound, X-rays, Endoscopy, Esophagogastroduodenoscopy
Brief summary
The present study is a prospective, single-center study. A total of 88 patients, who had placed a pancreatic stent for preventing post-ERCP pancreatitis, will be included in the study. Aim of the study is to establish a new algorithm based on a sonographic approach to remove the placed pancreatic stents. Another aim is to compare high-end sonographic devices with devices of medium price scale one's used on the ward. On the day of removal of the pancreatic stent, all patients receive a sonography by an experienced investigator on the ward and by another, uninformed investigator with a high-end device. If a pancreatic stent is visualized in the pancreatic duct, the patient will have an esophagogastroduodenoscopy to remove the pancreatic stent. If sonography cannot find a pancreatic stent in the pancreatic duct an x-ray will be performed as suggested by the European and international guidelines. If the pancreatic stent spontaneously dislocated into the small bowel tract according to x-ray, no further investigation will be performed. If a stent is visulized in situ by x-ray, it will be removed by endoscopyl. Statistical analysis will be done in cooperation with the statistical biomedical institute oft he university hospital in Frankfurt.
Interventions
DIAGNOSTIC_TESTSonographic based visualization of a pancreatic stent
As described above. All patients start with an ultasound-based approach to visualize pancreatic stents position. Depending on the findings, x-ray will be performed if no stent is visualized in the pancreatic duct or an esophagogastroduodenoscopy will be performed to remove the pancreatic stent and confirm sonographic findings if the pancreatic stent is displayed in situ.
Sponsors
Johann Wolfgang Goethe University Hospital
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Neither the investigator nor the patient will know before the sonographic approach, if the pancreatic stent is still in place. The diagnosis will be confirmed either by endoscopic findings or by x-ray depending on sonographic diagnosis and further algorithm.
Intervention model description
The participants will start with a diagnostic ultrasound to visualize a pancreatic stent. If a stent is being displayed in the pancreatic duct. The participants will undergo endoscopy for removal of the pancreatic stent. Otherwise, x-ray will be performed to confirm the sonographic diagnosis. Stents, that are visulized in the duct by x-ray will than be removed. If sonography and x-ray confirm a spontanous dislodgement of the pancreatic stent, no further investigation will be performed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* placement of prophylactic pancreatic stent to prevent post-ERCP-pancreatitis * age of at least 18 years * written informed consent
Exclusion criteria
* diseases that prevent sonography, x-ray or esophagogastroduodenoscopy * no given consent * other indication for pancreatic stenting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirmation of a new algorithm to remove a prophylactic pancreatic stent placed to prevent post-ERCP pancreatitis by using sonography as first approach and compare the findings statistically in a pivot table to x-ray and endoscopy. | The entire procedure will take place within one hour. | A new algorithm is supposed to be tested that starts with a sonography to display a pancreatic stent. If the pancreatic stent can be visualized in the pancreatic duct, an esophagogastroduodenoscopy will be performed directly to remove the stent. If the stent cannot be displayed by sonography, x-ray will be performed as commonly suggested by the European and international guidelines. Therefore, the main goal of the study is to implement sonography before further diagnostic modalities to confirm prophylactic pancreatic stents position in the pancreatic duct. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the findings of high-end sonographic devices and the findings of medium prize sonographic devices used on the ward by using a pivot table. | Both will take place within 30 minutes. | There will be performed two different ultrasounds to confirm stents position by two different experienced investigators. The results will be compared to the results of x-ray and/or endoscopy to evaluate the quality of high end to medium prize sonographic devices. |
| Univariate analysis of the baseline characteristics compared to the results of sonographic findings to evaluate risk factors of false sonographic findings by using a Case report form to collect the data. | The entire procedure will take place within one hour. | Baseline characteristics will be compared to the false-positive and false-negative results of sonography compared to the gold standard (x-ray/endoscopy) |
Countries
Germany
Outcome results
None listed